Kornimate/medical-research-clean huggingface dataset:
randomized trial of nsaid vs placebo prior to ureteral stent removal

Conditions: Disorder of Urinary Stent; Ureteral Spasm; Ureteropelvic Junction Obstruction; Urolithiasis

Summary: this study plans to learn more about whether ibuprofen can reduce pain after removal of a ureteral stent more than a placebo. some patients experience pain after removal of a ureteral stent. the investigators plan to learn how often this occurs and whether it can be prevented. the investigators hypothesize that children who have a temporary, indwelling ureteral stent will experience a significantly less post-operative pain if given a non-steroidal anti-inflammatory (nsaid) prior to removal of the ureteral stent when compared to placebo. the investigators hypothesize that the incidence of severe post-stent removal pain is similar to an adult population.


Eligibility criteria:
inclusion criteria: * ages 4-17 * unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis exclusion criteria: * bilateral stents * undergoing other concomitant procedure at time of planned ureteral stent removal * indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis * pregnant * developmental delay * allergy to ibuprofen or non-steroidal anti-inflammatory medication class * chronic kidney disease * prior renal transplant * history of nasal polyps * history of asthma

Keywords: ureteral stent stent pain ureteral spasm nsaid ibuprofen placebo ureteropelvic junction obstruction urolithiasis
a clinical decision support system and patient portal for preventing medication-related falls in older patients

Conditions: Fall; Fall Injury; Fall Patients; Accidental Fall; Deprescriptions; Polypharmacy; Aged; Aged, 80 and Over

Summary: falls in older adults represents a growing public health challenge. the use of certain medication is recognized as an important modifiable risk factor for falls. research indicates fall-risk increasing drug (frid) deprescribing is effective in reducing falls but difficult to initiate and to sustain over longer periods of follow-up. a clinical decision support system (cdss) and patient portal for communicating medication-related fall risk to fall clinic patients may improve joint medication management between patients and physicians and consequently reduce the incidence of injurious falls.

this study investigates the effectiveness and cost-effectiveness of the concurrent use of a cdss and a patient portal for personalized frid deprescribing, and will be assessed through a multicenter cluster-randomized controlled trial among new fall clinic patients, aged 65 years or older. the main study parameter is the time to first injurious fall. the primary objective of the adfice_it study is to investigate the effects of a cdss and accompanying patient portal for optimizing frid deprescribing on injurious falls. this study has three secondary objectives. first, the effect of the cdss and patient portal on a number of secondary outcomes will be investigated. second, a process evaluation to evaluate the implementation of the cdss and patient portal will be conducted. third, the cost-effectiveness of the cdss and patient portal will be investigated.

Eligibility criteria:
inclusion criteria: * history of at least one fall in the past year; * a mini-mental state examination (mmse) score of 21 points or higher or equivalently a montreal cognitive assessment (moca) dutch score of 16 points or higher; * use of at least one fall-risk increasing drug (frid); and * sufficient command of the dutch language in speech and writing. exclusion criteria: * active participation in another study; * life expectancy of less than one year: and/or * suffering from severe mobility impairment (i.e. bedridden, e.g. inability to walk short distances with assistance of a walking aid).

Keywords: fall prevention fall-risk increasing drugs (frids) older out-clinic patients injurious falls prediction model clinical decision support system patient portal shared decision making (sdm) medication withdrawal
trial of chinese prescription shugan decoction on irritable bowel syndrome（diarrhea type）

Conditions: Irritable Bowel Syndrome; Traditional Chinese Medicine

Summary: the purpose of this study is to evaluate the efficacy and safety of the chinese prescription shugan decoction on irritable bowel syndrome（diarrhea type）.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of irritable bowel syndrome（diarrhea type） * male of female patients between 18-65 years old * written informed consent exclusion criteria: * discrepancy of irritable bowel syndrome * diarrhea-type of irritable bowel syndrome combine with intestinal disease * combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease. * pregnancy or breast feeding women, or unwilling to have contraception.

Keywords: alternative medicine
efficacy of autologous adipose derived stromal vascular fraction for musculoskeletal conditions

Conditions: Knee Osteoarthritis

Summary: clinical efficacy of autologous stromal vascular fraction svf,for inflammatory and degenerative conditions of the knees

to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (svf) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

Eligibility criteria:
inclusion criteria: * knee osteoarthritis any grade * knee chondromalacia grade 2 and above exclusion criteria: * active hiv * pregnant women * mental disease * severe cardio vascular disease * severe coagulation disorders * infected tissues * patients on other experimental studies within 3 months

Keywords: knee osteoarthritis knee chondromalacia
graded repetitive arm supplementary program versus task based training on upper limb function in stroke patients

Conditions: Stroke; Upper Extremity Paresis; Motor Activity

Summary: to determine effects of graded repetitive arm supplementary program versus task based training on upper limb function in stroke patients.

this study will be randomized clinical trial. a total of 38 stroke patients will be recruited by using non-probability convenience sampling technique. patients will be randomized and allocated into two interventional groups based on the inclusion and exclusion criteria. patients in group a will receive graded repetitive arm supplementary program and patients in group b will receive task based training. all participants will receive the treatment for 40 minutes per session, 5 days per week for 5 weeks. for the evaluation of all participant scales like be chedoke arm and hand activity inventory for clinical relevance, fugl mayer assessment scale for performance assessment, action reach arm test for coordination and dexterity and motor activity log for functional assessment of upper limb in stroke patients. d

Eligibility criteria:
inclusion criteria: * patients with sub acute stage of stroke. * patients with ischemic and haemorrhagic stroke. * patients with cognition level on mini mental state examination must be \> 24 * patients with mild pain in upper extremity according to numeric pain rating scale * patients with grade 2 active movements in affected extremity tone of upper limb at modified ashworth scale grade 1+. exclusion criteria: * other neurological disorders e.g. brain tumor, encephalitis, meningitis, brain abscess. * use of antipsychotics * use of drugs for spasticity. * patients with vestibular impairment.

Keywords: stroke upper extremity paresis motor activity
mirdametinib + bgb-3245 in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: a phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with bgb-3245 in adult participants with histologically confirmed, advanced (american joint committee on cancer (ajcc) stage iii or iv) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.


Eligibility criteria:
key inclusion criteria: * able to provide informed consent * at least 18 years of age on day of signing icf * advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated. * part 1: oncogenic mutation or other genomic aberration of the mapk pathway * part 2: oncogenic mutation or genomic aberration defined below: * cohort a: cutaneous melanoma harboring nras mutations. * cohort b: non-small cell lung cancer (nsclc) harboring a kras mutation. * cohort c: nsclc or cutaneous melanoma harboring braf class ii or class iii mutations or braf fusion mutation. * must have archival tumor tissue or agree to a fresh tumor biopsy at screening * measurable disease per recist 1.1 * eastern cooperative oncology group (ecog) performance status of ≤ 2 * adequate organ function and no transfusion within 14 days of first dose key exclusion criteria: * central nervous system metastases, leptomeningeal carcinomatosis or untreated spinal cord compression * history of glaucoma * active parathyroid disorder or history of malignancy associated hypercalcemia * clinically significant cardiac disease within the past 6 months of signing icf * history of toxicity from another raf, mek, erk inhibitor requiring discontinuation of treatment from these agents * severe or uncontrolled systemic disease * inability to swallow oral medications * clinically significant active infection (hiv, hepatitis b or hepatitis c) * history of or ongoing immune thrombocytopenia (itp), von willebrand disease and/or other past or present bleeding disorders * underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study * major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study * systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose * concomitant systemic or glucocorticoid therapy within 2 weeks before first dose * concomitant medicines that are strong cyp3a4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose * live vaccine within 4 weeks before first dose
acute stress response in migraine sufferers

Conditions: Migraine Headache

Summary: this study will examine the influence of stress and fasting on headache activity. participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits.

stress and headache are intricately interrelated. stress is thought to contribute to headache disorder onset in predisposed individuals, trigger or worsen individual headache episodes in those with headache, and exacerbate the progression of a headache disorder. in exacerbating headache disorder progression, stress is believed to be a major factor in headache transformation from an episodic to a chronic condition. broadly stated, stress is conceptualized as an imbalance between a demand, whether actual or perceived, and resources to handle the demand, resulting in a strain on the system. a stressor is any challenge or threat, whether objectively verified or not, to normal functioning. the stress response is the body's activation of physiological systems to protect and restore functioning. this study is 2 x 2 experiment using male and female migraine sufferers. participants will be randomized to a fasting or not fasting condition for the visits. thus, the experiment is a 2 (control versus stress) x 2 (fasting versus not). during the approximately 4 weeks of participation (ranging from 9 to a maximum of 28 days), a participant also will complete a twice-daily diary.

Eligibility criteria:
inclusion criteria: * women and men 18-65 years of age * a provisional diagnosis of migraine (with or without aura). * headache frequency of 2 to 15 attacks/month exclusion criteria: * presence of a secondary headache disorder (e.g., brain tumor) * chronic daily headache (\> 15 headache days/month) or medication over-use headache (\> 8 abortive medication doses/month) * recent change in nature of headache symptoms over last 6 weeks * not being able to read or speak english at a 6th grade level * any condition that would preclude the safe experience of a benign laboratory stressor including seizure disorder, axis-i psychotic disorder, unstable cardiac conditions * an active substance dependence issue (e.g., alcohol, marijuana) that interferes with data collection and headache activity.

Keywords: stress fasting migraine
mucus removal before embryo transfer

Conditions: Infertility; Embryo Transfer

Summary: despite these revolutionary changes in the laboratory, little has changed with the process of embryo transfer (et). a study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in art will be undertaken.

et involves placing the embryo(s) obtained before assisted reproduction technology (art) into the uterus via a catheter advanced through the cervical canal. yet this is the final, and in some respects the most critical, process in the sequential events that encompass an art cycle. if an embryo cannot be delivered to the uterine cavity atraumatically and in a location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval, embryo culture, and embryo selection will have no benefit. contamination of the catheter with blood may be a marker for difficult et and has also been linked to poor et outcomes. when retrospectively assessing outcomes, goudas et al. (1) demonstrated a clinical pregnancy rate of 50% with no blood, and this rate fell by half when a small amount of blood was noted on the catheter tip. pregnancy rates fell even further, to 10%, when there was a significant amount of blood (1). similarly, in a preliminary study, blood or mucus on the tip was associated with a significantly lower pregnancy outcome (2). blood and mucus were associated with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8, respectively. although all these data suggest a possible role of cervical mucus in embryo transfer, there is no clinical evidence on the effect of removal of cervical mucus on the outcome of ivf/icsi. in view of this uncertainty, a study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in art will be undertaken. it is hypothesized that removal of cervical mucus will achieve higher clinical pregnancy rates.

Eligibility criteria:
inclusion criteria: * ivf or od patients with supernumerary embryos (oocyte's age will be considered as patient's age). * normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for art with respect to uterus and adnexa * single embryo transfer * embryo transfer at the blastocyst stage * embryo with a morphological classification of ≥3bb exclusion criteria: * preimplantation genetic diagnosis and/or screening

Keywords: embryo transfer flushing catheter pregnancy rate frozen embryo tranfer
an early feasibility study evaluation of an implant free interatrial shunt to improve heart failure

Conditions: Heart Failure; Heart Failure NYHA Class III; Heart Failure With Reduced Ejection Fraction; Ambulatory Heart Failure, NYHA Class IV

Summary: the purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. the primary goal is to determine if the device is safe to use. the findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.

this is a prospective, multicenter, single-arm early feasibility study (efs) to evaluate the safety of the intershunt pas-c system in subjects with heart failure, and the feasibility of pas-c to improve heart failure related symptoms. the device is used to create an interatrial shunt by removing septal tissue to reduce left atrial pressure. there is no permanent implant. enrollment will include 20 subjects with documented heart failure who may benefit from the reduction of left atrial pressure. the primary objective of this study is to characterize the safety of using the pas-c system by evaluating the proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization through one month after the procedure. the findings from this study will be used to develop a subsequent pivotal study.

Eligibility criteria:
inclusion criteria: * nyha class ii at screening with a prior history of greater than nyha class ii, or nyha class iii at screening, or ambulatory class iv at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. * at least one hospitalization for heart failure or treatment with iv diuretics for heart failure or elevated bnp in the prior 12 months. * receiving maximally tolerated guideline directed medical therapy for heart failure management. * lvef ≥ 20% and ≤ 40% according to baseline echocardiography. * resting right heart catheterization demonstrates elevated pcwp compared to right atrial pressure. exclusion criteria: * any of the following within the prior 6 months: stroke, thromboembolism, severe or advanced heart failure such as stage d heart failure, non-ambulatory nyha class iv, cardiac index less than 1.8 l/min/m2, lvedd \> 8 cm, or received inotropic therapy for lvef less than 20%. * any of the following within the prior 3 months: myocardial infarction percutaneous cardiac intervention, cabg, on cardiac transplant list, cardiac resynchronization therapy implant, aicd implant, or indicated for coronary revascularization at the time of enrollment. * transseptal procedure or percutaneous cardiac intervention planned within the next 6 months. * chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease. * patent foramen ovale (pfo) device or atrial septal defect (asd) device. * bmi \> 40. * anatomic anomaly that precludes creation of interatrial shunt.
the desarda and lichtenstein techniques in inguinal hernia treatment.

Conditions: Hernia, Inguinal

Summary: contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. the implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. the research to find any new hernioplasty without the use of meshes is still going on. desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. these results were comparable with the effects of lichtenstein technique. the initial assessment done in our own department revealed good clinical results after hernia treatment with desarda's method. to make appropriate and objective clinical assessment of the desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (rct) was projected and conducted. finally, 105 patients were included in the desarda group and 103 in the lichtenstein group. personal clinical follow up was made up to 3 years after operation. generally no statistically significant differences were found between these groups. the only difference was higher rate of seroma after lichtenstein technique and different pain perception in both groups. to the summary it is clear that desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. the rct was done with the use of sharepoint portal server (microsoft) which seems to be appropriate for clinical trials.


Eligibility criteria:
inclusion criteria: * primary inguinal hernia * male adults * signed informed consent * god condition of external oblique aponeurosis (assessed during the operation) exclusion criteria: * age \< 18 * recurrent hernia * incarcerated hernia * diagnosed mental disorder * manual reduction of hernia on inpatient * infection at groin area * wound or scar at the groin * no consent

Keywords: inguinal hernia hernia recurrence no mesh techniques desarda technique
effect of lidocaine/dexamethasone on the success of ianb

Conditions: Local Anesthesia

Summary: the purpose of this prospective, randomized, double-blind study was to compare the success rate of ian block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. these investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. it is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block

Eligibility criteria:
inclusion criteria: * vital mandibular molar tooth * diagnosis of symptomatic irreversible pulpitis exclusion criteria: * younger than 18 years old * history of significant medical conditions * allergies to local anesthetics or sulfites * pregnancy * taking any medications that might influence anesthetic assessment * active sites of pathosis in area of injection * inability to give informed consent

Keywords: inferior alveolar nerve block irreversible pulpitis local anesthesia dexamethasone